MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	G38490
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported via email to customer relations: this event happened around 4 pm today (b)(6).A zilver ptx stent was being advanced through a calcified sfa, and it damaged the delivery catheter.At first it was being advanced over an.018 wire, and it wouldn't track, we switched out for an.035 wire and that's when we realized the delivery catheter of the stent deployment system was kinked because it wasn't tracking over the.035 wire.The stent wasn't deployed, and we successfully removed it all in one piece.There was no harm to the patient, and we were able to use a new stent (same size as the previous stent) and that one tracked and was successfully deployed.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 08-jul-2025.
Additional Manufacturer Narrative
Device evaluation: 1 unit of lot number c2226304 of zisv6-35-125-7-120-ptx was returned opened not in its original packaging.With the information provided, a physical examination and document-based investigation was conducted.Input received from our medical advisor confirmed that a calcified superficial femoral artery would be considered on-label use unless the lesion prevented stent placement.The device involved in the complaint was evaluated in the laboratory on 13 may 2025.The returned device lab findings and observations can be referred through the attached files.Visual inspection: red safety button returned intact.Crinkling noted along delivery system approx.21cms to 39cm from white distal tip.Functional inspection: device flushes as intended.0.035 inch wire guide unable to pass through device, beyond 38cms from white distal tip.Red safety button pressed.Stent deployed with no issue.Stent examined -no damage observed, gold rivets present on each end.Manufacturing records: prior to distribution, all zisv6-35-125-7-120-ptx devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for zisv6-35-125-7-120-ptx device of lot number c2226304 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and label: the precautions section of the instructions for use (ifu0118), which accompanies this device instructs the user "a 0.035 inch (0.89mm) diameter wire guide should be used during tracking, deployment, and removal in order to ensure adequate support of the system" there is evidence to suggest that the customer did not follow the instructions for use.(ifu0118) image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could be attributed to use error.It may be noted the device label indicates a 0.035¿ wire guide for use with this device and all simulated use testing to date has been completed using a 0.035¿ wire guide.As per information provided a 0.018" wireguide was used.The reported issue of the delivery system being kinked consequently making it difficult to track over the wireguide would have been caused by use of the incorrect wireguide.Engineering input also stated that the use of the 0.018" wireguide would not have provided sufficient support to the device, resulting in kinking on the delivery system.Use error complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.Confirmation of complaint: complaint is confirmed based on visual/functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the customer, there was tracking difficulty experienced when the zilver ptx stent was being advanced.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient did not suffer any adverse effects.Investigation findings conclude that a definitive root cause could be attributed to use error.It may be noted the device label indicates a 0.035¿ wire guide for use with this device and all simulated use testing to date has been completed using a 0.035¿ wire guide.As per information provided a 0.018" wireguide was used.The reported issue of the delivery system being kinked consequently making it difficult to track over the wireguide would have been caused by use of the incorrect wireguide.Engineering input also stated that the use of the 0.018" wireguide would not have provided sufficient support to the device, resulting in kinking on the delivery system.Use error complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 21857652
• Report Number: 3001845648-2025-00199
• Device Sequence Number: 11942251
• Product Code: NIU
• UDI-Device Identifier: 10827002384900
• UDI-Public: (01)10827002384900(17)260910(10)C2226304
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P100022/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2026
• Device Model Number: G38490
• Device Catalogue Number: ZISV6-35-125-7-120-PTX
• Device Lot Number: C2226304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/21/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown